|Biotech Quality Manager||06.06.2024 09:00 - 17:00 (Do)||Online||Dr. Christian Grote-Westrick|
The workshop focuses on all aspects of pharmaceutical quality management. This area represents an entrance opportunity for life scientists into industry. Quality managers´ daily business will be explained based on current regulations and laws which are obligatory to be implemented into industrial companies. Within the workshop several case studies will be used to offer in-sights into quality manager tasks and duties.
INTERACTIVE PART: participants will slip into the role of FDA inspectors who will evaluate gradings of real FDA findings. As is real life inspectors must justify their decisions based on cur-rent guidelines. To challenge this part, the docent will participate here and takes over the role of inspected company.
The workshop will effectively prepare students for daily business of quality managers and auditors since this position represents most frequently used access opportunity in industry.
How to apply quality management in pharma companies
Receiving a certification (ISO 9001 / 13485)
Job preparation in QM Pharma
Working as a quality auditor
Information delivery combined with case studies and interactive participation.
Final part will be a complete interaction of all participants:
Everyone receives a list of real FDA findings and categorizes them according to GMP standards. Trainer will take over the role of audited company to further challenge participants.
☒ Beginn der Promotion / Beginning of the doctorate
☒ Während der Promotion / During the doctorate
☒ Endphase der Promotion / End of the doctorate
(participants receive access data before the workshop)
Dr. Grote-Westrick studied biochemistry at Ruhr-University in Bochum followed by diploma thesis at Harvard Medical School, Boston, USA. After PhD Thesis at RUB and Yale School of Medicine Dr. Grote-Westrick started industry business at different biotech companies in various positions.
2000-2004 Biochemistry Studies (RUB, Harvard)
2004-2007 PhD in Biochemistry (RUB, Yale)
2007-2010 R&D Manager in Biotech Company imusyn
2010-2013 Production Manager in Biotech Company BDL
since 2013 Head of QA at B.Braun
Pharmaceutical QA Head, RP GDP, GMP Trainer
Freelancing GMP Trainer at international graduate schools
Member of Directors Board at European GDP Association